First-line treatment with chemotherapy plus cetuximab in Chinese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety results of the randomised, phase III CHANGE-2 trial

被引：26

作者：

Guo, Ye ^{[1
,19
]}

Luo, Yi ^{[2
]}

Zhang, Qingyuan ^{[3
]}

Huang, Xiaoming ^{[4
]}

Li, Zhengdong ^{[5
]}

Shen, Liangfang ^{[6
]}

Feng, Jifeng ^{[7
]}

Sun, Yan ^{[8
]}

Yang, Kunyu ^{[9
]}

Ge, Minghua ^{[10
]}

Zhu, Xiaodong ^{[11
]}

Wang, Lin ^{[12
]}

Liu, Yanyan ^{[13
]}

He, Xiaohui ^{[14
]}

Bai, Chunmei ^{[15
]}

Xue, Kai ^{[16
]}

Zeng, Yan ^{[17
,20
]}

Chang, XinYing ^{[17
]}

Chen, Wenfeng ^{[17
]}

Lin, Tongyu ^{[18
]}

机构：

[1] Fudan Univ, Med Oncol Dept, Canc Ctr, Shanghai, Peoples R China

[2] Hunan Canc Hosp, Hunan Sheng, Peoples R China

[3] Harbin Med Univ, Canc Hosp, Harbin, Peoples R China

[4] Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Guangzhou, Peoples R China

[5] Liaoning Canc Hosp & Inst, Liaoning Sheng, Peoples R China

[6] Cent South Univ, Xiangya Hosp, Hunan Sheng, Peoples R China

[7] Jiangsu Canc Hosp, Nanjing, Peoples R China

[8] Peking Univ Canc Hosp, Beijing, Peoples R China

[9] Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Wuhan, Peoples R China

[10] Zhejiang Prov Peoples Hosp, Hangzhou, Peoples R China

[11] Guangxi Med Univ, Affiliated Tumor Hosp, Nanning, Guangxi, Peoples R China

[12] Hai Nan Gen Hosp, Internal Med 1, Haikou, Hainan, Peoples R China

[13] Zhengzhou Univ, Dept Internal Med, Affiliated Canc Hosp, Zhengzhou, Peoples R China

[14] Chinese Acad Med Sci, Canc Hosp, Beijing, Peoples R China

[15] Peking Union Med Coll Hosp, Beijing, Peoples R China

[16] Fudan Univ, Shanghai Canc Ctr, Shanghai, Peoples R China

[17] Merck Serono Co Ltd, Merck KGaA, Beijing, Peoples R China

[18] Sun Yat Sen Univ, Dept Med Oncol, Canc Ctr, 651 Dongfeng East Rd, Guangzhou 510060, Peoples R China

[19] Tongji Univ, Shanghai East Hosp, Dept Med Oncol, Shanghai, Peoples R China

[20] Everest Med, Beijing, Peoples R China

来源：

EUROPEAN JOURNAL OF CANCER | 2021年 / 156卷

关键词：

Cetuximab; China; EXTREME; First-line; Recurrent and; or metastatic squamous cell carcinoma of the head and neck; OPEN-LABEL; PLATINUM; MULTICENTER; CISPLATIN; CANCER;

D O I：

10.1016/j.ejca.2021.06.039

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: The EXTREME regimen (chemotherapy [CT; cisplatin/carboplatin and 5-fluorouracil]) plus cetuximab is a standard-of-care first-line (1L) treatment for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN), as supported by international guidelines. The phase III CHANGE-2 trial assessed the efficacy and safety of a modified CT regimen (with a reduced dose of both components) and cetuximab versus CT for the 1L treatment of Chinese patients with R/M SCCHN. Methods: Patients were randomised to receive up to six cycles of CT plus cetuximab followed by cetuximab maintenance until progressive disease or CT alone. The primary end-point was the progression-free survival (PFS) time assessed by the independent review committee (IRC). Results: Overall, 243 patients were randomised (164 to CT plus cetuximab; 79 to CT). The hazard ratios for PFS by IRC and overall survival (OS) were 0.57 (95% CI: 0.40-0.80; median: 5.5 versus 4.2 months) and 0.69 (95% CI: 0.50-0.93; median: 11.1 versus 8.9 months), respectively, in favour of CT plus cetuximab. The objective response rates (ORR) by IRC were 50.0% and 26.6% with CT plus cetuximab and CT treatment, respectively. Treatment emergent adverse events of maximum grade 3 or 4 occurred in 61.3% (CT plus cetuximab) and 48.7% (CT) of patients. Conclusions: CHANGE-2 showed an improved median PFS, median OS and ORR with the addition of cetuximab to a modified platinum/5-fluorouracil regimen, with no new or unexpected safety findings, thereby confirming CT plus cetuximab as an effective and safe 1L treatment for Chinese patients with R/M SCCHN. Clinical trial registration number: NCT02383966. 2021 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

引用

页码：35 / 45

页数：11

共 20 条

[1]

Agency EM, 1998, ICH E5 R1 ETHNIC FAC

[2]

[Anonymous], Head and neck cancer

[3] Prognostic factors and long-term survivorship in patients with recurrent or metastatic carcinoma of the head and neck - An analysis of two Eastern Cooperative Oncology Group randomized trials [J].

Argiris, A ;

Li, Y ;

Forastiere, A .

CANCER, 2004, 101 (10) :2222-2229

[4] Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study [J].

Burtness, Barbara ;

Harrington, Kevin J. ;

Greil, Richard ;

Soulieres, Denis ;

Tahara, Makoto ;

de Castro, Gilberto, Jr. ;

Psyrri, Amanda ;

Baste, Neus ;

Neupane, Prakash ;

Bratland, Ase ;

Fuereder, Thorsten ;

Hughes, Brett G. M. ;

Mesia, Ricard ;

Ngamphaiboon, Nuttapong ;

Rordorf, Tamara ;

Ishak, Wan Zamaniah Wan ;

Hong, Ruey-Long ;

Mendoza, Rene Gonzalez ;

Roy, Ananya ;

Zhang, Yayan ;

Gumuscu, Burak ;

Cheng, Jonathan D. ;

Jin, Fan ;

Rischin, Danny .

LANCET, 2019, 394 (10212) :1915-1928

[5] Cancer Statistics in China, 2015 [J].

Chen, Wanqing ;

Zheng, Rongshou ;

Baade, Peter D. ;

Zhang, Siwei ;

Zeng, Hongmei ;

Bray, Freddie ;

Jemal, Ahmedin ;

Yu, Xue Qin ;

He, Jie .

CA-A CANCER JOURNAL FOR CLINICIANS, 2016, 66 (02) :115-132

[6] Consensus recommendations for management of head and neck cancer in Asian countries: A review of international guidelines [J].

D'cruz, A. ;

Lin, T. ;

Anand, A. K. ;

Atmakusuma, D. ;

Calaguas, M. J. ;

Chitapanarux, I. ;

Cho, B. C. ;

Goh, B. C. ;

Guo, Y. ;

Hsieh, W. S. ;

Hu, C. ;

Kwong, D. ;

Lin, J. C. ;

Lou, P. J. ;

Lu, T. ;

Prabhash, K. ;

Sriuranpong, V. ;

Tang, P. ;

Vu, V. V. ;

Wahid, I. ;

Ang, K. K. ;

Chan, A. T. .

ORAL ONCOLOGY, 2013, 49 (09) :872-877

[7]

Global Cancer Observatory, Cancer Today

[8] A meta-analysis comparing cisplatin-based to carboplatin-based chemotherapy in moderate to advanced squamous cell carcinoma of head and neck (SCCHN) [J].

Guan, Jian ;

Li, Qinyang ;

Zhang, Yue ;

Xiao, Nanjie ;

Chen, Min ;

Zhang, Yaowei ;

Li, Lu ;

Chen, Longhua .

ONCOTARGET, 2016, 7 (06) :7110-7119

[9] Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial [J].

Guigay, Joel ;

Auperin, Anne ;

Fayette, Jerome ;

Saada-Bouzid, Esma ;

Lafond, Cedrik ;

Taberna, Miren ;

Geoffrois, Lionnel ;

Martin, Laurent ;

Capitain, Olivier ;

Cupissol, Didier ;

Castanie, Helene ;

Vansteene, Damien ;

Schafhausen, Philippe ;

Johnson, Alison ;

Even, Caroline ;

Sire, Christian ;

Duplomb, Sophie ;

Evrard, Camille ;

Delord, Jean-Pierre ;

Laguerre, Brigitte ;

Zanetta, Sylvie ;

Chevassus-Clement, Cecile ;

Fraslin, Alderic ;

Louat, Fanny ;

Sinigaglia, Laura ;

Keilholz, Ulrich ;

Bourhis, Jean ;

Mesia, Ricard .

LANCET ONCOLOGY, 2021, 22 (04) :463-475

[10] Platinum-based chemotherapy plus cetuximab first-line for Asian patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: Results of an open-label, single-arm, multicenter trial [J].

Guo, Ye ;

Shi, Mei ;

Yang, Ankui ;

Feng, Jifeng ;

Zhu, Xiaodong ;

Choi, Young-Jin ;

Hu, Guoqin ;

Pan, Jianji ;

Hu, Chunhong ;

Luo, Rongcheng ;

Zhang, Yiping ;

Zhou, Liang ;

Cheng, Ying ;

Luepfert, Christian ;

Cai, Junliang ;

Shi, yuankai .

HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK, 2015, 37 (08) :1081-1087

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